To address the complex ethical questions arising in the field of biological research, science and medicine, our global Johnson & Johnson Bioethics Committee (JJBC), led by our Chief Medical Officer, serves as an advisory body to our worldwide teams on ethical issues. Composed of a diverse group of employees from across the business, JJBC assists in ethics-based decision making in line with the fundamental principles of bioethics, including beneficence, non-maleficence, autonomy and justice, and in accordance with our Ethical Code for the Conduct of Research and Development. We also engage with industry and continue to make a strong contribution to the dialogue on current bioethical issues, in particular, clinical trial data transparency and access to investigational medicines.
Access to Investigational Medicines
Pre-approval access (PAA) is an overarching term for access to an investigational medicine outside of a clinical trial and prior to health authority approval. The main pathway for gaining access to Janssen’s investigational medicines is for a patient to enroll in a clinical trial. For patients with serious or life-threatening illnesses who cannot enroll in clinical trials, PAA programs can be considered.
Our commitment to transparent and ethically based decision making is illustrated through efforts such as our robust and patient-centered development of strategies to make investigational medicines available to those in need, as well as our collaboration with the New York University School of Medicine to create the Compassionate Use Advisory Committee (CompAC). CompAC facilitates the review of compassionate use requests by an independent, external body of internationally recognized medical experts, bioethicists and patient representatives. After a successful pilot that began in 2015, CompAC was expanded to include additional investigational medicines in development at Janssen. Further, Johnson & Johnson’s commitment extends industrywide to support patients, providers and caregivers in their efforts to understand potential options available to them. The CompAC process has been recognized as a leading practice by experts in bioethics.
Our Commitment to Animal Welfare
Some of our R&D processes that deliver immeasurable benefit to human health are made possible through rigorous research and testing. Where this research involves animals, we employ every method available to safeguard their welfare.
This research is overseen by our Animal Care Council and functional councils. Our Policy on the Humane Care and Use of Animals directs our operating companies on the ethical and humane treatment of animals and promotes the use of non-animal alternatives whenever feasible. We have had a Refinement, Reduction and Replacement (3Rs) program in place for over 12 years that annually recognizes and promotes significant advances and innovative approaches to improve the wellbeing of animals in our studies and the development of alternative methods. We also partner with the Institute for In Vitro Sciences and the Center for Alternatives for Animal Testing to develop viable non-animal research alternatives.
In addition, our Policy requires that research protocols involving the use of animals are reviewed for approval by the Animal Care and Use Committees or Ethical Committees and are compliant with appropriate local and regional governmental agencies. It also requires all personnel to be appropriately trained, and all Johnson & Johnson animal facilities to be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).
Five Years of Responsible Clinical Trial Data Sharing
Sharing clinical trial data advances the science that is the foundation of medicine and public health by enabling researchers and scientists to test new hypotheses and potentially find new treatments and cures. Since 2014, Johnson & Johnson has partnered with the Yale University School of Medicine and the Yale Open Data Access (YODA) Project. The YODA Project serves as an independent, third-party reviewer of external requests for access to data from clinical trials conducted by Johnson & Johnson for our pharmaceuticals, medical devices and consumer products—enabling a fair and unbiased approach for assessing external research proposals.
Five-year data on the YODA Project were published in Nature’s open access journal, Scientific Data, in 2018. The research findings both defined best practices for sharing clinical trial data and outlined outstanding challenges to further refine how data are shared.
By responsibly sharing our data, we aim to pave the way for better healthcare data-sharing practices to improve health outcomes for the greatest number of people.